An open science pathway for drug marketing authorization-Registered drug approval

Area of Science:

• Pharmacology and Drug Development
• Regulatory Science

Background:

• The process for approving new drugs is complex and requires clear evaluation criteria.
• Ensuring patient safety and drug efficacy necessitates a robust regulatory pathway.

Purpose of the Study:

• To propose a novel pathway for the evaluation and approval of new drugs.
• To outline registered criteria essential for drug assessment and regulatory clearance.

Main Methods:

• Literature review on existing drug approval processes.
• Development of a framework based on registered criteria for evaluation.
• Analysis of key stages in drug development and regulatory submission.

Main Results:

• A proposed pathway with defined stages for drug evaluation.
• Identification of specific registered criteria for assessing drug safety and efficacy.
• A structured approach to streamline the drug approval process.

Conclusions:

• The proposed pathway offers a systematic method for drug evaluation and approval.
• Implementing registered criteria can enhance the transparency and efficiency of regulatory processes.
• This framework aims to facilitate the timely availability of safe and effective new drugs.